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  • White, R James (author)

Combination Therapy with Oral Treprostinil for Pulmonary Arterial Hypertension. A Double-Blind Placebo-controlled Clinical Trial.

  • Article/chapterEnglish2020

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  • 2020

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  • LIBRIS-ID:oai:gup.ub.gu.se/292315
  • https://gup.ub.gu.se/publication/292315URI
  • https://doi.org/10.1164/rccm.201908-1640OCDOI

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  • Language:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

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  • Rationale: Oral treprostinil improves exercise capacity in patients with pulmonary arterial hypertension (PAH), but the effect on clinical outcomes was unknown.Objectives: To evaluate the effect of oral treprostinil compared with placebo on time to first adjudicated clinical worsening event in participants with PAH who recently began approved oral monotherapy.Methods: In this event-driven, double-blind study, we randomly allocated 690 participants (1:1 ratio) with PAH to receive placebo or oral treprostinil extended-release tablets three times daily. Eligible participants were using approved oral monotherapy for over 30 days before randomization and had a 6-minute-walk distance 150 m or greater. The primary endpoint was the time to first adjudicated clinical worsening event: death; hospitalization due to worsening PAH; initiation of inhaled or parenteral prostacyclin therapy; disease progression; or unsatisfactory long-term clinical response.Measurements and Main Results: Clinical worsening occurred in 26% of the oral treprostinil group compared with 36% of placebo participants (hazard ratio, 0.74; 95% confidence interval, 0.56-0.97; P = 0.028). Key measures of disease status, including functional class, Borg dyspnea score, and N-terminal pro-brain natriuretic peptide, all favored oral treprostinil treatment at Week 24 and beyond. A noninvasive risk stratification analysis demonstrated that oral treprostinil-assigned participants had a substantially higher mortality risk at baseline but achieved a lower risk profile from Study Weeks 12-60. The most common adverse events in the oral treprostinil group were headache, diarrhea, flushing, nausea, and vomiting.Conclusions: In participants with PAH, addition of oral treprostinil to approved oral monotherapy reduced the risk of clinical worsening.Clinical trial registered with www.clinicaltrials.gov (NCT01560624).

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  • Jerjes-Sanchez, Carlos (author)
  • Bohns Meyer, Gisela Martina (author)
  • Pulido, Tomas (author)
  • Sepulveda, Pablo (author)
  • Wang, Kuo Yang (author)
  • Grünig, Ekkehard (author)
  • Hiremath, Shirish (author)
  • Yu, Zaixin (author)
  • Gangcheng, Zhang (author)
  • Yip, Wei Luen James (author)
  • Zhang, Shuyang (author)
  • Khan, Akram (author)
  • Deng, C Q (author)
  • Grover, Rob (author)
  • Tapson, Victor F (author)
  • Hjalmarsson, Clara,1969Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine(Swepub:gu)xhjacl (author)
  • Göteborgs universitetInstitutionen för medicin, avdelningen för molekylär och klinisk medicin (creator_code:org_t)
  • Göteborgs universitet
  • Gothenburg University

Related titles

  • In:American journal of respiratory and critical care medicine201:6, s. 707-7171535-4970

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